DETAILED ACTION
The Office Action is in response to the Applicant's reply filed February 27, 2026 to the non-final rejection made on August 27, 2025.
Claims 1, 3, 6-14, 16-23 are currently pending and are examined on the merits herein.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Application Priority
This application filed 03/13/2023 is a 371 of PCT/US2021/071479 filed on 09/16/2021 which has provisional 17/023,269 filed on 09/16/2020.
Information Disclosure Statement
No new information disclosure statement(s) (IDS) filed.
Response to Arguments
Applicant’s arguments over the 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph of claims 6-7, and 11-12 are persuasive. The rejection is herewith withdrawn.
The rejection of claims 1-2, 6, 8-22 under 35 U.S.C. 102(a)(1) as being unpatentable over Rothstein et al. (Treatment of vitiligo with the topical Janus kinase inhibitor ruxolitinib. J Am Acad Dermatol. 2017 Jun;76(6):1054-1060.e1. doi: 10.1016/j.jaad.2017.02.049. Epub 2017 Apr 5. PMID: 28390737 - IDS), as evidenced by Incyte. Investigator’s Brochure (IB) INCB018424 Phosphate Cream. Report date April 10, 2015. is persuasive in view of the amendments made to the claims. The rejection is herewith modified.
The rejection of claims 1-3, 6, 9-17, 20-23 under 35 U.S.C. 102(a)(1) as being unpatentable over Alomran et al. (Treatment of vitiligo with the topical Janus kinase inhibitor ruxolitinib: a 32-week open-label extension study with optional narrow-band ultraviolet B. J Am Acad Dermatol 2018; 78:1205-1207 - IDS) is persuasive in view of the amendments made to the claims. The rejection is herewith modified.
The rejection of claims 1-23 under 35 U.S.C. 102(a)(1) as being unpatentable over Rosmarin et al. (Ruxolitinib cream for treatment of vitiligo: a randomised, controlled, phase 2 trial. Lancet. 2020 Jul 11;396(10244):110-120. doi: 10.1016/S0140-6736(20)30609-7. PMID: 32653055 - IDS) as evidenced by Incyte. Investigator’s Brochure (IB) INCB018424 Phosphate Cream. Report date April 10, 2015 is not persuasive. The rejection is herewith modified. The Applicant argues the Rosmarin reference does not provide the results at 104 weeks. The Examiner’s contention is that the same formulation applied for the same condition at the same duration would inherently have the same results.
The rejection of claims 3, 5, 7, 23 under 35 U.S.C. 103(a) as being unpatentable over Rothstein et al. (Treatment of vitiligo with the topical Janus kinase inhibitor ruxolitinib. J Am Acad Dermatol. 2017 Jun;76(6):1054-1060.e1. doi: 10.1016/j.jaad.2017.02.049. Epub 2017 Apr 5. PMID: 28390737), as evidenced by Incyte. Investigator’s Brochure (IB) INCB018424 Phosphate Cream. Report date April 10, 2015), as applied to claims 1-2, 6, 8-22 above is not persuasive. The rejection is herewith maintained.
The rejection of claims 4, 5, 7 under 35 U.S.C. 103(a) as being unpatentable over Alomran et al. (Treatment of vitiligo with the topical Janus kinase inhibitor ruxolitinib: a 32-week open-label extension study with optional narrow-band ultraviolet B. J Am Acad Dermatol 2018; 78:1205-1207), as applied to claims 1-3, 6, 9-17, 20-23 aboveis not persuasive. The rejection is herewith maintained.
The rejection of claims 8, and 18-19 under 35 U.S.C. 103(a) as being unpatentable over Alomran et al. (Treatment of vitiligo with the topical Janus kinase inhibitor ruxolitinib: a 32-week open-label extension study with optional narrow-band ultraviolet B. J Am Acad Dermatol 2018; 78:1205-1207), as applied to claims 1-3, 6, 9-17, 20-23 above, in view of Rothstein et al. (Treatment of vitiligo with the topical Janus kinase inhibitor ruxolitinib. J Am Acad Dermatol. 2017 Jun;76(6):1054-1060.e1. doi: 10.1016/j.jaad.2017.02.049. Epub 2017 Apr 5. PMID: 28390737), as evidenced by Incyte. Investigator’s Brochure (IB) INCB018424 Phosphate Cream. Report date April 10, 2015) is not persuasive. The rejection is herewith maintained.
Applicant argues that a skilled artisan would not have had any motivation to extend the treatment period, neither would the skilled artisan have had a reasonable expectation of success in extending the administration period to 104 weeks, and that such repigmentation could be maintained for at least 3 months after discontinuing treatment. Outside of a general statement of "successful results" the Office provide no evidence suggesting that such a motivation existed. Id.
In response, the Examiner points out that the arguments do not commensurate in scope with the claims. The claims do not require a period of 104 weeks, but at least 104 weeks – which reads on indefinite treatment.
The rejections are as follows:
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 3, 6-14, 16-23 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. The Examiner points out that the use of ‘at least 104 weeks’ reads on indefinite use of the formulation, while Applicant’s data does not commensurate in scope with at least 104 weeks.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
Claims 1, 3, 6-14, 16-23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rosmarin et al. (Ruxolitinib cream for treatment of vitiligo: a randomised, controlled, phase 2 trial. Lancet. 2020 Jul 11;396(10244):110-120. doi: 10.1016/S0140- 6736(20)30609-7. PMID: 32653055 - IDS) as evidenced by Incyte. Investigator's Brochure (IB) INCB018424 Phosphate Cream. Report date April 10, 2015.
Rosmarin et al. teaches treatment with ruxolitinib cream (1.5% twice daily was associated with substantial repigmentation of vitiligo lesions up to 52 weeks of treatment, and all doses were well tolerated. All patients could receive open-label ruxolitinib cream 1.5% twice daily for an additional 104 weeks (part 3). The primary endpoint was the proportion of patients given ruxolitinib cream who had a 50% or higher improvement from baseline in F-VASI score (F-VASI50) at week 24 versus vehicle. The median age was 49.0 years (range 18-73). - Patients had depigmentation of 0.5% or more of their facial body surface area (BSA) and 3% or more of their non-facial BSA Incyte Corporation provided the supply of study drug. The drug is an oil-water emulsion cream in phosphate form.
With respect to the limitation that that the repigmenting is durable after discontinuating topical administration for at least 3 months, the Examiner states the same formulation applied for the same condition at the same duration would inherently have the same results.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 3, 6-14, 16-23 are rejected under 35 U.S.C. 103 as being unpatentable over Rothstein et al. (Treatment of vitiligo with the topical Janus kinase inhibitor ruxolitinib. J Am Acad Dermatol. 2017 Jun;76(6):1054-1060.e1. doi: 10.1016/j.jaad.2017.02.049. Epub 2017 Apr 5. PMID: 28390737), as evidenced by Incyte. Investigator’s Brochure (IB) INCB018424 Phosphate Cream. Report date April 10, 2015).
Rothstein et al. teaches twice-daily topical ruxolitinib 1.5% cream, a Janus kinase inhibitor, in a 20-week open-label study for vitiligo treatment (Abstract: Objective and Methods). Four patients had significant facial vitiligo affecting [0.5% BSA of the face (one half of a hand unit) per VASI at baseline. Four patients with significant facial involvement at baseline had a 76% improvement in facial Vitiligo Area Scoring Index scores at week 20. A minimum of 1% body surface area (BSA) affected by vitiligo was required for inclusion at screening. Topical application of ruxolitinib was limited to 10% BSA, or maximum 3.75 grams per application, to minimize systemic exposure. The mean age range is 50 in the study.
Incyte Corporation provided the supply of study drug. The drug is an oil-water emulsion cream in phosphate form.
Rothstein teaches the duration of the trial for 20 weeks, but fails to teach durably for at least 6 months or administration for at least 52/104 weeks as claimed, a testing of improvement at week 24, and maintaining re-pigmentation for at least 6 months following administration.
However, it would have been obvious to one of ordinary skill in the art at the time of filing to extend treatment as needed for a patient or follow-up on analysis of the treatment regimen. The motivation to extend treatment or follow-up is because Rothstein teaches successful results with ruxolitinib treatment and vitiligo has a major impact on patients’ quality of life, while topical steroids, calcineurin inhibitors, and phototherapy are the mainstay of treatment for vitiligo but are used with limited success. A skilled artisan would have reasonable expectation of success in extending treatment as needed.
Claims 1, 3, 6-7, 9-14, 16-17, 20-23 are rejected under 35 U.S.C. 103 as being unpatentable over Alomran et al. (Treatment of vitiligo with the topical Janus kinase inhibitor ruxolitinib: a 32-week open-label extension study with optional narrow-band ultraviolet B. J Am Acad Dermatol 2018; 78:1205-1207).
Alomran et al. teaches treatment of vitiligo with the twice-daily application of topical topical Janus kinase inhibitor ruxolitinib 1.5% cream in a 32-week open-label extension study with optional narrow-band ultraviolet B. Application of the cream was limited to 10% of the body surface area or 3.75 g/application. Five participants were followed up with at 6 months after treatment discontinuation, and all 5 participants maintained response with maximum duration of more than 40 weeks. Two patients developed new lesions on areas not being treated, while none of the treated areas got worse. A mean improvement of 16.7% ± 35.6% was seen in Physician Global Vitiligo Assessment, a mean improvement of 1.5 was seen in Dermatology Life Quality Index, and the change in body surface area was 20.78% ± 35.35% at week 52. In patients with >0.5% facial surface area affected (n = 4), a statistically significant mean improvement of 92% ± 7.1%, (P = .0001) in facial VASI was seen at week 52. The mean age range is 50 in the study.
Alomran teaches a 32-week open-label extension study and statistically significant mean improvement of VASI at week 52, but fails to teach administration for at least 52/104 weeks as claimed, and a testing of improvement at week 24.
However, it would have been obvious to one of ordinary skill in the art at the time of filing to extend treatment as needed for a patient or follow-up on analysis of the treatment regimen. The motivation to extend treatment or follow-up is because Alomran teaches successful results with ruxolitinib treatment. A skilled artisan would have reasonable expectation of success in extending treatment as needed and analyze the results of such treatment.
Claims 8, 18 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Alomran et al. (Treatment of vitiligo with the topical Janus kinase inhibitor ruxolitinib: a 32-week open-label extension study with optional narrow-band ultraviolet B. J Am Acad Dermatol 2018; 78:1205-1207), as applied to claims 1, 3, 6-7, 9-14, 16-17, 20-23 above, in view of Rothstein et al. (Treatment of vitiligo with the topical Janus kinase inhibitor ruxolitinib. J Am Acad Dermatol. 2017 Jun;76(6):1054-1060.e1. doi: 10.1016/j.jaad.2017.02.049. Epub 2017 Apr 5. PMID: 28390737), as evidenced by Incyte. Investigator’s Brochure (IB) INCB018424 Phosphate Cream. Report date April 10, 2015).
Alomran et al. is as discussed above.
Alomran et al. does not specify the drug form.
Rothstein et al. teaches Incyte Corporation provided the supply of study drug.
Incyte Corporation provided the supply of study drug. INCB018424 Phosphate Cream is an oil-water emulsion cream in phosphate form.
it would have been obvious to one of ordinary skill in the art at the time of filing to incorporate the INCB018424 Phosphate Cream. The motivation to incorporate the INCB018424 Phosphate Cream is because Rothstein teaches Incyte Corporation provided the supply of study drug. INCB018424 Phosphate Cream is an oil-water emulsion cream in phosphate form. A skilled artisan would have reasonable expectation of success in using the INCB018424 Phosphate Cream.
Conclusion
No claims are allowed.
The arguments are not persuasive and the rejection is made FINAL.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/LAYLA SOROUSH/ Primary Examiner, Art Unit 1622
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